ACETIC ACID solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)

Disponible desde:

A-S Medication Solutions

Designación común internacional (DCI):

ACETIC ACID

Composición:

ACETIC ACID 20.65 mg in 1 mL

Vía de administración:

AURICULAR (OTIC)

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial. Hypersensitivity to acetic acid or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal. Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Resumen del producto:

Product: 50090-0351 NDC: 50090-0351-0 15 mL in a BOTTLE / 1 in a BOX

Estado de Autorización:

New Drug Application

Ficha técnica

ACETIC ACID- ACETIC ACID SOLUTION
A-S MEDICATION SOLUTIONS
----------
ACETIC ACID OTIC SOLUTION, USP
RX ONLY
DESCRIPTION
Acetic Acid Otic Solution, USP is a solution of acetic acid (2%) in a
propylene glycol
vehicle containing propylene glycol diacetate (3%), benzethonium
chloride (0.02%), and
sodium acetate (0.015%). The empirical formula for acetic acid is CH
COOH, with a
molecular weight of 60.05. The structural formula is:
Acetic Acid is available as a nonaqueous otic solution buffered at pH
3 for use in the
external ear canal.
CLINICAL PHARMACOLOGY
Acetic acid is antibacterial and antifungal; propylene glycol is
hydrophilic and provides a
3
low surface tension; benzethonium chloride is a surface active agent
that promotes
contact of the solution with tissues.
INDICATIONS AND USAGE
For the treatment of superficial infections of the external auditory
canal caused by
organisms susceptible to the action of the antimicrobial.
CONTRAINDICATIONS
Hypersensitivity to acetic acid or any of the ingredients. Perforated
tympanic membrane
is considered a contraindication to the use of any medication in the
external ear canal.
WARNINGS
Discontinue promptly if sensitization or irritation occurs.
PRECAUTIONS
Transient stinging or burning may be noted occasionally when the
solution is first
instilled into the acutely inflamed ear.
PEDIATRIC USE
Safety and effectiveness in pediatric patients below the age of 3
years have not been
established.
ADVERSE REACTIONS
Stinging or burning may be noted occasionally; local irritation has
occurred very rarely.
DOSAGE AND ADMINISTRATION
Carefully remove all cerumen and debris to allow acetic acid to
contact infected surfaces
directly. To promote continuous contact, insert a wick of cotton
saturated with acetic
acid into the ear canal; the wick may also be saturated after
insertion. Instruct the
patient to keep the wick in for at least 24 hours and to keep it moist
by adding 3 to 5
drops of acetic acid every 4 to 6 hours. The wick may be removed after
24 hours but
the patient should continu